A Study to Follow Patients With Adult Growth Hormone Deficiency (AGHD) Treated With Sogroya® for Long Term Safety Information

June 11, 2026 updated by: Novo Nordisk A/S

A Multi-national, Multi-centre, Prospective, Single-arm, Observational, Non-interventional Post-authorisation Safety Study to Investigate Long-term Safety of Sogroya® (Somapacitan) in Adults With Growth Hormone Deficiency (AGHD) Under Routine Clinical Practice

In this study, the general long-term safety and effectiveness of Sogroya (somapacitan) in adults with growth hormone deficiency (AGHD) being treated per normal clinical practice is looked into. In the study, information on side effects and how well Sogroya (somapacitan) works during long term treatment in people with Adult Growth Hormone Deficiency (AGHD) will be collected and analysed. Participants will be treated with Sogroya (somapacitan) as prescribed by the study doctor, in accordance with normal clinical practice. The study will last for 5-10 years, depending on when the participant join the study. The participant will be asked to complete two short questionnaires during every visit to the clinic. The questionnaires will collect information on the participant's well-being, work ability and ability to perform daily activities.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bron, France, 69500
        • HCL - HOPITAL LOUIS PRADEL - Service d'endocrinologie
      • Lille, France, 59000
        • CHU LILLE - HOPITAL CLAUDE HURIEZ - Service d'endocrinologie et diabétologie
      • Marseille, France, 13005
        • APHM - HOPITAL DE LA CONCEPTION - Service d'endocrinologie, nutrition, diabète et obésité
      • Paris, France, 75013
        • APHP - LA PITIE SALPETRIERE_Service endrocrinologie et medecine de la reproduction
      • Reims, France, 51100
        • CHU REIMS - HOPITAL ROBERT DEBRE - Service Endocrinologie-Diabète-Nutrition
  • Germany
      • Aachen, Germany, 52074
        • Uniklinik Aachen - Endokrinologie und Diabetologie
      • Frankfurt am Main, Germany, 60596
        • Endokrinologikum Frankfurt
      • Halle, Germany, 06120
        • Universitätsklinikum Halle - Innere Medizin III
      • Mainz, Germany, 55131
        • Universitätsmedizin der JGU Mainz - Endokrinologie und Stoffwechselerkrankungen
      • München, Germany, 81667
        • Medicover Neuroendokrinologie MVZ
      • München, Germany, 81667
        • Medicover Neuroendokrinologie MVZ München
      • München, Germany, 80336
        • LMU Klinikum Großhadern München - Med. Klinik
      • Oldenburg, Germany, 26122
        • Medicover Oldenburg MVZ
      • Oldenburg, Germany, 26122
        • Medicover MVZ Oldenburg
      • Würzburg, Germany, 97080
        • Universitätsklinikum Würzburg - Zentrum für Innere Medizin (ZIM)
  • Japan
      • Chikushino-shi, Fukuoka, Japan, 818-8502
        • Fukuoka University Chikushi Hospital_Endocrinology and Diabetes Mellitus
      • Kagoshima-shi, Kagoshima, Japan, 890-8520
        • Kagoshima University Hospital_Neurosurgery
      • Kawasaki-shi, Kanagawa, Japan, 211-8533
        • Nippon Medical School Musashikosugi Hospital_Neurological Surgery
      • Kobe-shi, Hyogo, Japan, 650-0017
        • Kobe University Hospital_Diabetes and Endocrinology
      • Okayama-shi, Okayama, Japan, 700-8558
        • Okayama University Hospital_General Medicine
      • Osaka-shi, Osaka, Japan, 534-0021
        • Osaka City General Hospital_Endocrinology and Diabetes Mellitus
  • Saudi Arabia
      • Jeddah, Saudi Arabia
        • My clinic
      • Jeddah, Saudi Arabia, 23323
        • Dr Soliman Fakeeh Hospital
      • Riyadh, Saudi Arabia, 59046
        • King Fahad Medical City
      • Riyadh, Saudi Arabia, 11643
        • Dr. Sulaiman Al Habib Medical Group- Olaya
  • Slovenia
      • Ljubljana, Slovenia, 1000
        • UKC Ljubljana, Endocrinology and Diabetes
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Barrow Neurological Institute
    • California
      • Los Angeles, California, United States, 90095
        • UCLA Health
      • Los Angeles, California, United States, 90033
        • Keck Medical Center of USC - Outpatient Clinic
      • Palo Alto, California, United States, 94304
        • Stanford Univ School of Med
      • Westminster, California, United States, 92683
        • Advanced Rx Clinical Research
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Anschutz Outpatient Pavilion
    • Florida
      • West Palm Beach, Florida, United States, 33401
        • Metabolic Research Institute Inc
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Atlanta Diabetes Associates
    • Illinois
      • Chicago, Illinois, United States, 60642
        • Northwestern Medical Group
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
      • Boston, Massachusetts, United States, 02115
        • Brigham & Women's Hospital
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • UNMC
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Palm Research Center Inc-Vegas
      • Reno, Nevada, United States, 89511
        • Northern Nevada Endocrinology
    • New York
      • New York, New York, United States, 10021
        • Cornell University
      • New York, New York, United States, 10017
        • NYU Langone Orthopedic Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • University of North Carolina
      • Greenville, North Carolina, United States, 27834
        • Physicians East Endocrinology
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University
    • Pennsylvania
      • Center Valley, Pennsylvania, United States, 18034
        • St Lukes Physician Group
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center-CRU
      • Dallas, Texas, United States, 75231
        • Revival Research Institute, LLC
      • El Paso, Texas, United States, 79935
        • EP Premier Medical Group PA
      • Shavano Park, Texas, United States, 78231
        • Consano Clinical Research, LLC
    • Washington
      • Seattle, Washington, United States, 98108-1597
        • Puget Sound VA, University of Washington
      • Seattle, Washington, United States, 98195-6165
        • University Of Washington_Seattle

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants with Adult Growth Hormone Deficiency

Description

Inclusion Criteria:

  1. Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
  2. The decision to initiate treatment with commercially available Sogroya (somapacitan) has been made by the participant and the treating physician before and independently from the decision to include the participant in this study.
  3. Male or female, age above or equal to 18 years assigned to Sogroya (somapacitan) treatment at the time of signing informed consent.
  4. Diagnosis of adult growth hormone deficiency (AGHD) as per local practice.

Exclusion Criteria:

  1. Previous participation in this study. Participation is defined as signed informed consent.
  2. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
  3. Participant with hypersensitivity to the active substance or to any of the excipients.
  4. Participant with active malignancy or in treatment for active pre-existing malignancy.
  5. Participant with acute critical illness, suffering from complications following open heart surgery, abdominal surgery, multiple accidental trauma, acute respiratory failure or similar conditions per investigator judgement.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Participants with Adult Growth Hormone Deficiency (AGHD)
Participants will be treated with commercially available Sogroya according to routine clinical practice at the discretion of the treating physician. The decision to treat a participant with Sogroya has been made prior to and independently from the decision to include the participant in this study.
Drug: Somapacitan
Sogroya therapy in participants with AGHD.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Adverse drug reaction (ADRs)
Time Frame: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Measured as count of events.
From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Incident Neoplasm
Time Frame: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Measured as number of participants (yes/no).
From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Incident Diabetes Mellitus type 2
Time Frame: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Measured as number of participants (yes/no).
From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Adverse Events (AEs)
Time Frame: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Measured as count of events.
From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Number of Serious Adverse Events (SAEs)
Time Frame: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Measured as count of events.
From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Number of Medication Errors (incorrect dose administration rate)
Time Frame: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Measured as count of errors.
From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Change in Insulin-like Growth Factor I (IGF-I) standard deviation score (SDS)
Time Frame: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Measured as score ranging from -10 to +10.
From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Patient achieving Insulin-like Growth Factor I (IGF-I) standard deviation score (SDS target) (0-+2)
Time Frame: Approximately (closest routine clinical) 12 months after enrolment in study
Measured as number of participants (yes/no).
Approximately (closest routine clinical) 12 months after enrolment in study
Change in Weight
Time Frame: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Measured as kilogram (kg).
From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Change in Body Mass Index (BMI)
Time Frame: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Measured as kilogram per square meter (kg^m2).
From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Change in waist circumference
Time Frame: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Measured as centimeter (cm).
From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Change in waist-hip ratio
Time Frame: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Measured as ratio.
From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Change in lipid profile (cholesterol, High Density Lipoprotein [HDL], Low Density Lipoprotein [LDL], triglycerides)
Time Frame: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Measured as milligrams per deciliter (mg/dL).
From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Change in glycated hemoglobin (HbA1C)
Time Frame: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Measured as percentage (%).
From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Change in bone density
Time Frame: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Measured as grams per square centimeter (g/cm^2).
From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Change in bone mineral content
Time Frame: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Measured as grams (g).
From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Change in total body fat-mass
Time Frame: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Measured as kg.
From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Change in truncal fat-mass
Time Frame: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Measured as kg.
From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Change in lean body mass
Time Frame: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Measured as kg.
From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Change in body fat percentage
Time Frame: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Measured as %.
From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Change in visceral adipose tissue (VAT)
Time Frame: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Measured as cm^2.
From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Change in Liver function (Aspartate aminotransferase [AST], Alanine transaminase [ALT], Gamma-Glytamyltransferase [GGT], bilirubin)
Time Frame: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Measured as Units per liter (U/L).
From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Change in Patient reported outcome (PRO) score, Treatment Related Impact Measure-Adult Growth Hormone Deficiency (TRIM-AGHD)
Time Frame: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Measured as score ranging from -100 to +100. Lower score indicates a better health state.
From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Patient reaching satisfactory clinical response
Time Frame: Approximately (closest routine clinical) 12 months after enrolment in study
Measured as number of participants (yes/no).
Approximately (closest routine clinical) 12 months after enrolment in study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novo Nordisk A/S

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 3, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2032

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2032

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 30, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 8, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NN8640-4515
  • U1111-1264-8642 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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